Status:
RECRUITING
A Study of Stereotactic Radiosurgery (SRS) to Treat Pain in the Chest and/or Stomach Wall
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Varian Medical Systems
Conditions:
Thoracoabdominal Wall Pain
Secondary to Parietal Pleura or Parietal Peritoneum Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The researchers are doing this study to find out whether stereotactic radiosurgery (SRS) is a safe, practical (feasible), and effective treatment for people with chronic TAWP. The researchers will tes...
Eligibility Criteria
Inclusion
- Patients must have a documented history of chronic (≥ 3 months) thoracoabdominal wall pain (TAWP) attributable to ≤ 3 unilateral spinal levels as confirmed by diagnostic paravertebral nerve block or TENS (if results of the paravertebral nerve block are inconclusive) performed by an attending anesthesiologist specializing in pain management prior to study enrollment.
- Patients must have TAWP that is inadequately relieved by a trial of conventional pharmacologic therapy (defined as NRS pain score ≥ 4/10 while on treatment with conventional pharmacologic therapy for analgesia) as determined by an attending physician specializing in pain management.
- KPS ≥ 60%
- Age ≥ 18 years old
Exclusion
- Patients with a life expectancy of \< 6 months as predicted by the Adult Comorbidity Index (ACE-27, see Appendix 1)
- Patients with active autoimmune connective tissue disease
- Patients with bilateral TAWP
- Patients with preexisting pneumothorax
- Patients with preexisting excessive pleural effusion (extending \> 3 vertebral levels)
- Systemic chemotherapy delivered or planned to be delivered within +/- 5 days of SRS
- Unable to undergo a diagnostic paravertebral nerve block
- Unable to undergo at least one of either a myelogram or spine MRI
- Patients for whom external beam treatment plans to deliver the prescription SRS dose to the lesion of interest cannot be safely designed as specified by the Dose Constraint Guidelines in Appendix 2
- Evaluation of any radiation doses previously delivered to spinal cord/cauda equina and other critical structures (bowel, esophagus, lungs, kidneys, rectum) will be taken into consideration
- If radiation dose from SRS would exceed any normal tissue constraint as noted in Appendix 2, the patient will be ineligible
- Abnormal complete blood count. Any of the following:
- Platelet count \< 75 K/µL
- Hgb level \< 9 g/dl
- WBC \< 3.5 K/µl
- Abnormal coagulation profile: INR \> 2.5 INR and/or APTT \> 80 seconds. Patients who are on anticoagulation medication that may not be safely held for the myelogram procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded.
- Allergy to local anesthestics
- Local infection at the site of injection of anesthetic
- Severe spinal deformities with anatomic distortion (severe scoliosis/kyphoscoliosis)
- Severe respiratory disease (i.e. oxygen dependent)
Key Trial Info
Start Date :
August 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05985148
Start Date
August 2 2023
End Date
August 1 2028
Last Update
January 16 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725